Develops, implements and manages DS/DP production process validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies' requirements and related SOPs. The position holder is also responsible for conceptual setup of continued process verification strategy and is single point of contact for process validation topics eg. HA inspections.
• Establish, write, maintain Validation Master Plan for process validation
• Support MS&T Head in ensuring that responsible departments execute and maintain the VMP activities including, annual revalidation process procedures.
• Maintain overview of validation state across sites.
• Partner with Quality based on feedback (e.g. via regulatory inspections, changes in regulations) to establish and maintain common approach
• Partner with Engineering and IT to define the process validation/ equipment/systems qualification interface.
• Develop the strategy for continued process verification (CPV) and annual monitoring batches that ensures all critical process parameters and quality attributes are monitored or analyzed, and actions taken in case of trends or deviations. Reviews risk assessments for CPV.
• Ensure CPV plans are in place to monitor and trend critical process parameters, quality attributes.
• Establish and manage the respective validation plans by aligning, coordinating and supervising the prioritization of activities against the business needs. Reviews risk assessments for validation.
• Set procedures & templates for respective validation documentation and validation master plan, provide guidance to facility impact and component criticality assessments.
• Maintain all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities.
• Author complex validation protocols (e.g. launches, transfers, weak point remediation).
• Review or author routine re-validation protocols and reports, reviews Master Batch Records (MBRs), associated change controls and supports the execution at the shop floor.
• Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
• Support equipment process qualification for new technologies. Ensure consistency with process needs defined by Manufacturing and/or Engineering.
• Participate in improvement and remediation of products.
• Be a senior advisor in case of difficult validation challenges.
• Understand potential risk areas/shortfalls and make sure that the site validation program is always inspection ready.
• Ensure a proper prioritization approach for Product Assessments, product validation, compliance activities.
• Leads the validation group and is responsible for his team members.
If this role is of interest to you, apply now for immediate consideration.
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